AccessGUDID - DEVICE: POWERWAND™ XL (00859821006681)

GUDID

Device Identifier (DI) Information

Brand Name: POWERWAND™ XL
Version or Model: Alternate Site Kit 4Fr x 10cm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 80701
Company Name: ACCESS SCIENTIFIC, LLC

Primary DI Number: 00859821006681
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079290879 *Terms of Use

Device Description: The POWERWAND™ XL Introducer with Extended Dwell Catheter, 4Fr x 10cm

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40601	Peripheral vascular catheter	A sterile, thin, flexible tube intended to be inserted into the peripheral vasculature of a patient to enable short-term (< 30 days) intravascular access; it is not intended to be advanced to the central vasculature. It typically includes dedicated accessories to facilitate catheter introduction/placement and function (e.g., connectors, injection ports, stylet and/or wings for fixation). It may be used for blood sampling, monitoring of blood pressure, to administer fluids, medication and/or for the injection of contrast media. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DYB	Introducer, Catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131300	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Protect from direct contact with sun, water, and humidity
Storage Environment Temperature: between 32 and 1004 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Pressure: 325 Pound per Square Inch
Needle Gauge: 21 Gauge
Length: 10 Centimeter
Catheter Gauge: 4 French

Device Record Status

Public Device Record Key: de355e95-88f4-4579-b844-5a1f45c104f2
Public Version Date: October 25, 2018
Public Version Number: 1
DI Record Publish Date: September 24, 2018